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Bio-Path Holdings Completes First Dose Cohort in Phase 1/1b Clinical Trial of BP1001-A for Solid Tumors

Saturday, July 15, 2023

Bio-Path Holdings, a biotechnology company focused on developing targeted nucleic acid cancer drugs using its DNAbilize® antisense RNAi nanoparticle technology, has announced the successful completion of the first dose cohort in the Phase 1/1b clinical trial of BP1001-A (liposomal Grb2). This trial is being conducted in patients with solid tumors, including ovarian, endometrial, pancreatic, and breast cancer.

Peter Nielsen, the President and CEO of Bio-Path Holdings, expressed his satisfaction with the completion of the first cohort, emphasizing the favorable safety profile of BP1001-A, which is crucial for the treatment of these vulnerable cancer patients. This milestone allows the company to progress to the second cohort of the study in solid tumor cancers, with the aim of completing enrollment by the end of 2023.

The dose escalation portion of the Phase 1/1b clinical trial is currently underway at several prominent cancer centers in the United States, including The University of Texas MD Anderson Cancer Center, The Mary Crowley Cancer Research Center, and Karmanos Cancer Center. The initial phase of the trial involves treating a total of nine evaluable patients with BP1001-A monotherapy, using a standard 3+3 design. The starting dose is 60 mg/m2, followed by subsequent doses of 90 mg/m2 and 135 mg/m2. The treatment cycle consists of two doses per week over four weeks, resulting in a total of eight doses administered within a twenty-eight day period. Following the successful completion of the BP1001-A monotherapy cohorts, the Phase 1b portion of the study will evaluate the safety and efficacy of BP1001-A in combination with paclitaxel for recurrent ovarian or endometrial tumors, as well as BP1001-A with gemcitabine for metastatic pancreatic tumors.

In the first dose cohort, three patients were enrolled, including one with hepatic lesions and lung metastases, and two with advanced gynecologic lesions. These patients had undergone extensive previous chemotherapies and/or surgeries for their conditions prior to participating in the Phase 1 study. No treatment-related adverse events or adverse events attributed to the study drug were reported for any of the patients.

BP1001-A is a modified drug product based on Bio-Path's lead candidate, prexigebersen. It incorporates formulation enhancements to create smaller drug nanoparticles, aiming to improve the drug's effectiveness by facilitating its release into the tumor's interior. Preclinical studies in mice have shown a reduction in tumor burden with the smaller nanoparticle formulation, indicating enhanced efficacy of the drug product.

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